A Phase II Study of Paclitaxel and Topotecan With Filgrastim-SD/01 Support For Relapsed and Refractory Aggressive Non-Hodgkin's Lymphoma

• Status: Completed
• Trial end date: 2004-04-27
• Target enrollment: 0
• Participant gender: All

Summary

For patients with relapsed and refractory aggressive non-Hodgkin's lymphoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Lenograstim; Paclitaxel; Topotecan

Criteria

INCLUSION:

• Bidimensionally measurable current/refractory aggressive NHL (Diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, Ki-1+ALCL, peripheral T-cell lymphoma, mantle cell lymphoma & transformed lymphoma.)

• No more than 3 prior treatment regimens. No anti-lymphoma therapy within the past 3 weeks.

• Not be eligible for treatment of a higher priority.

• Performance status <2 Zubrod, > 60 Karnofsky.

• Good marrow reserve: ANC>1.5 x 10(9)/L, platelets > 100 x 10(9)/L.

• Bilirubin <1.5mg/dL, SGOT, SGPT < 2 x normal values.

• Serum creatinine < 1.8 mg/dL.

• Age > 18 yrs.

• Signed informed consent.

• Life expectancy of > 12 weeks.

• No prior Taxane (paclitaxel or docetaxel), topotecan, or CPT-11.

• No prior stem cell or bone marrow transplantation.

• No prior second malignancies except for basal cell carcinoma of the skin.

EXCLUSION:

• Active or prior history of CNS lymphoma.

• Serious intercurrent medical illnesses requiring hospitalization.

• History of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids).

• Prior exposure to Filgrastim-SD/01.

• Women who are pregnant or lactating.

• Participation in another clinical trial.

• Positive HIV antibody.

• History of prior sensitivity to E. coli derived products (such as filgrastim/neupogen).